steady state study [Design Issues]

posted by drcampos  – Brazil, 2007-08-13 21:11 (6894 d 08:41 ago) – Posting: # 980
Views: 2,911

❝ what is a steady state study? how and when is it done?


Dear drgopal,

The steady state study is made following multiple dose administration. In this case is essential to prove that steady state has been reached. Normally, multiple doses are administered for a period of at least five-times the terminal half-life.

This study is required to sustained-release formulations, drugs with low plasma concentration after a single dose (hormones) and drugs with non-linear pharmacokinetics, considering bioequivalence studies (ANDA). This kind of study is required to new drugs (NDA). Please, for more details see: FDA or EMEA guidances.

Regards,

Daniel

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
193 visitors (0 registered, 193 guests [including 22 identified bots]).
Forum time: 05:53 CEST (Europe/Vienna)

Most scientists today are devoid of ideas, full of fear, intent on
producing some paltry result so that they can add to the flood
of inane papers that now constitutes “scientific progress”
in many areas.    Paul Feyerabend

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5